Rimsys is a world-leading Regulatory Information Management (RIM) software for medical technology companies that digitizes, automates, and creates regulatory order. The only holistic RIM software for medical devices, in-vitro diagnostics, and medical device software, Rimsys makes it easy to navigate the pillars of regulatory affairs, including product registration, UDI, standards management, essential principles/GSPR, postmarket and regulatory intelligence. Rimsys is a holistic platform built by and for regulatory affairs professionals to efficiently ensure that products adhere to changing global regulations.

Medical Device Regulatory & Quality Consulting Services – Client-focused consulting services specially tailored to meet the needs of themedical device market and improve regulatory compliance, increase quality awareness, and expedite time-to-marketo Key Project #1: Philips Healthcare - Regulatory Project Lead responsible for operations, regulatory affairs, and quality system workstreams in the relocation of Philips Monitoring & Analytics Business Group manufacturing site (~$600M Annual Revenue) from Andover, MA to Pittsburgh, PA. The Business Group was under consent decree and in the midst of transition to the EU MDR. Additionally facilitated third-party audits, internal audits, and notified body audits required as part of the relocation. The result was zero third-party audit findings and zero Notified Body audit findings. All critical milestones were hit on time and no delay of certification or revenue generating product shipments.o Key Project #2: Confidential Company - International Taiwanese company under a Warning Letter by FDA for manufacturing products that were not validated. Regulatory Project Lead responsible for reengineering the manufacturing validation process, revalidating 2,000+ extruded products, maintaining active communication with FDA, and training the company on valid statistical techniques. All products were properly validated and the company’s Warning Letter was satisfied.

Carmell Therapeutics Corporation is a privately-owned biotechnology company focused on the development and commercialization of innovative Plasma-based Bioactive Materials (PBMs). These PBMs contain a concentration of natural regenerative factors that promote healing, reduce complications, and lead to healthcare savings.-Establish the Quality Management System (QMS) for pharmaceutical / biological (USA) and medical device (EU) implantableplasma-based bone putty products.-Prepare, draft and submit regulatory submissions such as IND, BLA and Design Dossier.

• Served as the Management Representative and managed all aspects of the Quality Management System (QMS)• Responsible for worldwide regulatory strategy, international product registrations/renewals, and regulatory submissions• Prepared and managed 510(k) submissions and technical file documentation• Managed complaint handling, vigilance reporting, medical device reporting, and post-market surveillance activities• Nurtured critical subcontractors into compliance with ISO13485, cGMP, and internal requirements• Prepared and submitted FDA Q-Subs and formulated regulatory and submission response strategies• Developed non-significant risk device clinical study protocols for use in the approval process with the Institutional Review Board (IRB)• Managed the product acquisition and ISO scope extension process with the Notified Body (LNE/GMED) and authorized representative (EMERGO)• Established a compliant QMS including complaint handling and adverse event reporting, eMDR, GUDID, UDI, change control, supplier management, and other systems as needed• Led FDA inspections, responded to 483 observations, and conducted remediation activities as appropriate

• Managed all aspects of the Quality Management System (QMS)• Responsible for all quality-related decisions regarding the company’s only commercial product, TissuGlu® Surgical Adhesive• Responsible for drafting the Sylys® Surgical Sealant Investigational Device Exemption (IDE) submission• Directly supported the company during the FDA's Medical Device Advisory Committee for TissuGlu® Surgical Adhesive with respect to presentation preparation, analysis and review of clinical trial data, and strategy of committee responses during panel meeting – the outcome of the meeting was a favorable vote for safety, efficacy, and risk benefit• Established the Unique Device Identification (UDI) process for the company, including compliance with HIBC Labeling requirements, revision of all product labels, and submission of label information to the Global Unique Device Identification Database (GUDID)• Responsible for preparing the company for US commercial distribution of its recently FDA approved product (TissuGlu® Surgical Adhesive) including vetting distribution partners, integrating the company’s quality system with sales support, establishing the Customer Service process with complaint handling requirements, and establishing the sales ordering and inventory process

• Maintained the Quality Management System (QMS) for Class III Medical Devices (TissuGlu® Surgical Adhesive and Sylys® Surgical Sealant) including Complaint Handling, Vigilance Reporting, Corrective and Preventive Actions (CAPA), Nonconformance Reporting (NCR), Post-Market Clinical Follow-up (PMCF), Engineering Change Control, Risk Management, Supplier Management, Auditing, and all other aspects of the QMS• Successfully completed business process reengineering for Risk Management, CAPA, Supplier Management, Training, Complaint Handling, Vigilance Reporting, Medical Device Reporting, Equipment Control, Sampling Plans, and other areas of the QMS to improve overall efficiency and efficacy while maintaining compliance • Established new QMS processes in engineering change control, device master record (DMR) control, qualification of equipment, and sampling• Drafted over 30% of the Pre-Market Approval (PMA) manufacturing module submission for TissuGlu® Surgical Adhesive• Identified and mitigated regulatory risk by improving CAPA timeliness by 40%; verified by 100% on-time metrics over the last five (5) quarters• Project lead tasked with preparing the company for FDA pre-approval inspection (PAI) within a three-month timeframe and successfully led the company through the FDA PAI with zero (0) observations• Project lead tasked with preparing Sylys® Surgical Sealant for CE marking and successfully drafted and submitted the Design Dossier to the company’s Notified Body (BSI) on May 9, 2014• Led the risk management process for TissuGlu® Surgical Adhesive and Sylys® Surgical Sealant and supported Design Verification & Validation (DV&V) activities for new product development• Developed and executed protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) on equipment and processes associated with cartridge filling and sealing and foil pouch sealing

• Initiated and actively managed distribution and manufacturing recalls• Drafted recall strategies for domestic and international products• Managed the Corrective and Preventive Action (CAPA) system• Performed Quality System and process audits including reporting, follow-up activities, and closure of nonconformities• Initiated delivery holds, product retention, and product dispositions• Led integration activities for a new complaint handling system (Trackwise) and a new instance of SAP (MP1)• Conducted User Acceptance Testing (UAT) on MP1 and Trackwise systems• Coordinated all Quality System training for entire business unit• Reviewed and revised Supplier Quality and Distribution Agreements• Responsible for ensuring that the targets for the business units’ Key Performance Indicators (KPIs) were met or exceeded on a monthly basis• Led quarterly Quality Management System Review presentations and monthly Quality Business Review (QBR) meetings with upper management

• Managed the entire Complaint Handling System within the Philips Children’s Medical Ventures (ChMV) business unit to maintain compliance with FDA regulation Title 21 CFR Part 820 & 803• Managed the chain of custody for products associated with adverse events• Reviewed and processed ChMV quality complaints in a uniform and timely manner ensuring accuracy and completeness• Drafted letters to customers, business institutions, and various regulatory agencies applying expertise of device performance and corresponding patient events• Identified potential reportable adverse events to ensure timely decision-making and preparation of Medical Device Reports (MDR) to the FDA• Implemented a Product Investigation Lab for Root Cause Analysis• Supported internal and external audits

• Supported four business segments and over 25 product lines with data analysis and reporting while meeting strict deadlines for the Home Healthcare Solutions business unit• Developed and executed custom SAP reports to determine corrective action effectiveness and supported Medical Device Reporting (MDR), Health Hazard Evaluation (HHE) and Post Market Risk Assessment (PMRA) investigations• Managed the quarterly Quality Management System Review presentation and led the monthly Quality Business Review (QBR) meetings with upper management• Co-led a complaint trending project that developed, automated, and implemented trending and forecasting tools in support of a Closed Loop CAPA system while maintaining compliance within the existing Quality System• Developed, documented, and implemented Microsoft Office SharePoint Server (MOSS) processes and procedures at a user-end for the Quality Systems department• Developed the User Acceptance Testing (UAT) test scripts for validation of an internal SharePoint website

• Taught Six Sigma Green Belt training modules on Basic Statistics, Minitab, Stability, Statistical Process Control, Process Capability, and Root Cause Analysis (5 Why’s)• Trained Project Managers and Design Quality Engineers in Minitab and Process Capability and helped develop test criteria for a Class II medical device• Developed methods to analyze Cost of Quality (CoQ) as it relates to Respironics Sleep and Home Respiratory Group and reported costs to Executive Management

• Conducted an analysis of Cost of Quality (CoQ) related to internal failure costs for a global leader in the sleep and home respiratory market• Developed a cost model to implement throughout products and facility to obtain non-quality costs on a weekly basis